In fact, KMC conducts more internal audits on itself than those initiated by third-parties, according to Gail Wiegand, Director of Quality Assurance and Regulatory Compliance at KMC.

Of the 26 quality audits conducted over the past 12 months at KMC by the FDA, ISO 13485 registrar, customers and internal management, 15 were performed by KMC.

A typical customer-requested audit takes one to two full days to complete on site at KMC - with less than two weeks’ advance notice.

KMC places great importance on having the audit information available for customers to review. As Wiegand explained, “Our customers have easy access to their data, their records and their procedures. We’re happy to take customers out to the manufacturing floor and have them look at our processes, talk to the personnel working on their program and see how we do things. We will show them any of our quality procedures if they ask and will show them any of the data that we collect and monitor as part of the management review. We let people see what they need to see in order to feel confident.”

The frequent audits are actually “really helpful,” Wiegand said.

“We never know when the FDA may want to perform an inspection,” she explained. “Frequent internal audits and customer audits help keep us on our toes. These ‘no observations’ inspections are a testimonial to how diligent the people are here at KMC who want to do the right thing on a daily basis.”

Additionally, the most recent FDA inspection was a more stringent level 2 inspection, covering all four modules of the FDA’s Quality Systems Inspection Technique Manual:

CAPA (Corrective and Preventive Action)

Production and Process Controls

Design Controls

Management Controls

In addition to complying with ISO 13485 and FDA Quality System Regulations (QSR), KMC is working with others toward keeping up with the ever changing harmonized standards for European regulations.

“We’re getting closer to meeting European standards,” Wiegand said. “Recently, we participated in a webinar on the 2012 version of risk management standard 14971 needed for Europe.”

In-house, the company has three key priorities for quality assurance:

Producing a safe and effective medical device that meet customers’ needs based on upfront communication with customers to define the product.

Maintaining a compliant quality management system (QMS) of procedures and processes, which meets the ISO 13485 standard and FDA regulations.

Determining the most cost-effective way to implement priorities #1 and #2.

The balancing act can be tough, Wiegand said, adding, “If we don’t maintain a quality system and products everyone can afford, we’re out of business.”

Plus, Quality Plans are customized for each product line, or what Wiegand calls a “focused factory cell.”

“We often can’t apply quality procedures broadly as there are little nuances with each product, and every customer wants something done a little differently,” Wiegand said. “So, we write a Quality Plan for each customer’s product line.”

With start-up customers, the Quality Plan can become another value-added component that KMC provides. These new companies, which have never been through the production process before, may not have considered some quality aspects in their manufacturing process.

“We think of things before they do,” Wiegand said.

Specifically, start-ups may be guided on:

How to package a device

What is important for testing purposes

The best approach for inspection of materials and consideration of source inspection at KMC

Quality Assurance Over Quality Control

“We practice quality assurance versus quality control, which would involve our group testing on the production floor,” she explained. “The difference is that if we were a quality control group, we may be the ones testing out on the floor and failing the instrument and saying ‘no’ it can’t go. From a quality assurance standpoint, we are trying to put preventive measures in place to do everything we can to assure a smooth assembly and testing process of the product on the floor, so the production personnel own the process and can decide if, due to a failure issue, the product can’t go. Also, from a quality assurance perspective, we are putting preventive measures in place to do everything we can to assure we receive good parts, review the procedures before we release them to see if we can prevent any assembly or test errors before they occur. For example, is there any ambiguity in the testing procedure?”

The quality assurance department, which has a team of 20 to 25 employees and contractors, has a “really good relationship” with KMC’s manufacturing team, which has 50 to 60 people, according to Wiegand.

The company is so committed to its Quality Policy that Wiegand reports directly to KMC’s President, Ron Jellison. This direct level of reporting ensures independent decision-making, alleviating any undue influence from any one particular functional group.

“The Quality Policy drives our decisions and helps us stay focused,” she said. “A goal of our Quality Policy is to create long-term relationships with customers and to ensure they can count on us to meet or exceed their needs and expectations.”

Wiegand stresses the Quality Policy is also in place to protect employees. “For employees, the Quality Policy focuses on giving them a safe environment in which to work” she said. “There are risks working in medical device manufacturing, such as having to test with blood samples to make some products; instruments with lasers; or chemicals to keep under control. We have a lot of policies in place to keep our employees safe and we also make sure our employees understand the industry standards to stay in compliance.”

Staying current

To stay abreast of changes and remain current with the latest in quality regulations and standards, KMC’s quality team is active in quality communities, shares information with management and within departments, holds training sessions and educates itself through conferences, webinar trainings and seminars.